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Search for Jobs by Kellie Pharr

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Senior Local Trial Manager - Canada (home based) (Research)
Toronto, QC M4B 1B5
Recruited by: Kellie Pharr | Recruiter | DOCS See all my Jobs

  • Hiring Company: DOCS
  • Industry: Research
  • Compensation: Salary
  • Expires: Dec 22, 2019
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Job Description

DOCS is hiring!  We have an excellent opportunity available for the right candidate!  DOCS is an excellent company that values their employees.  We have excellent benefits as well.  

Performs the role of Local Trial  Manager (LTM)  including operational  oversight of assigned protocol(s) from start-up through to database  lock and closeout activities as described  in GCO procedural documents. May perform the role of Global Trial Manager (GTM) for single country as described  in  GCO procedural documents.  LTM is a person within Trial Co-ordination  and Site Management  responsible for local management  of a trial (or Medical Affairs data generation  activities)  in a country or countries.  The LTM is the primary point of contact at a country level for assigned studies. The LTM is responsible for coordinating  and leading the local trial team in  order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating  Procedures (SOPs) and regulatory requirements. LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants,  Site Managers and LTMs.  The LTM may have some site management  responsibilities.    

JOB FUNCTIONS/RESPONSIBILITIES     

•       Is  responsible for country do-ability  and site feasibility  assessment  in conjunction  with CTA,  SM and GTM. Implements any local criteria for site selection.  Ensure consistent conduct of pre-trial assessment  visits and instruct teams on appropriate follow-up  of pre-trial visit report and country feasibility  report.  Recommends  suitable sites for selection to participate  in trial.
•     Collaborates  with the CPL,  GTM, local management/Country Head and Protocol Owner to select final site list.
•       Contributes  input to the Trial Plan, Safety Monitoring  Plan, Filing and Archiving  Plan and lnvestigational  Product documents  at a country level or initiates development  of these plans for a single country trial.
•     Leads and coordinates  local trial team activities in  compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI)  and applicable  regulations.  Leads local  project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget.  Including  but not limited to:  development  of local trial specific procedures and tools, recruitment  planning,  contingency  and risk management,  and budget forecasting.
•     Ensures that all SAEs/PQCs  are reported within reporting timelines and documented  as appropriate.
•    Maintains and updates trial management  systems (e.g.  CTMS, eTMF/LAF,  Trial Master Source and Sharepoints).  Uses study tools and management  reports available to analyze trial progress
•     Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates  study progress and issues to study management  teams.
•    May submit requests for vendor services and may support vendor selection.
•     May lead  negotiation of trial site contracts and budgets.  Forecasts and manages  country/local  trial budqet to ensure accurate finance reporting and trial delivered -within  budget.  
•     Attends/participates in  Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting
•       Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and  changes in study related processes).
•       Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the GTM and FM as needed
•    Reviews and approves site and local vendor invoices as required
•     Works with SM to ensure CAPP is implemented for  audits and inspection or any quality related visits
•    Complies with relevant training requirements.
•       Acts as local expert for assigned protocols.  Develops strong therapeutic  knowledge to support roles and responsibilities.  May represent Global Clinical Operations on cross functional teams.
•       Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders,  in particular investigators,  study trial coordinators  and other site staff;  and internal stakeholders,  including Medical Affairs and Marketing for Medical Affairs trials.
•     Actively contributes to process improvement; training and mentoring of Clinical Trial Administrators, Site Managers and other LTMs.
•       Internal Interfaces:  Functional Manager,  Partner with the CTAs, SMs, Quality & Compliance Managers/Experts,  Contracts and Grants associates. GTM, R&D study team (e.g.,  SRP). protocol owners, data management  and Medical Affairs (when applicable) to ensure overall trial coordination and site management activities for assigned protocols.
     

EXPERIENCE SKILLS, KNOWLEDGE REQUIREMENTS

•       Minimum six years of pharmaceutical  and/or clinical trial experience is preferred.    Specific therapeutic area experience may be required depending on the position.
•     Should have solid understanding  of the drug development  process including ICH/GCP and local regulatory requirements.
•       Should have solid understanding  of the drug development process including ICH/GCP and local regulatory requirements.    

EDUCATION REQUIREMENTS                                                                                  ..

•    A minimum of a BA/BS degree is required.  A degree in a health or science related field is preferred.